S02 D.1 QASP.pdf

Attachment D.1 36C25522Q0114 Quality Assurance Surveillance Plan (QASP)

Page 1 of 8 Version 0007 Date: 3/1/2018

The contractor will be evaluated in accordance with the following:

1. PURPOSE

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

• What will be monitored?

• How monitoring will take place.

• Who will conduct the monitoring?

• How monitoring efforts and results will be documented.

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor through contract modification. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (CO) – The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship.

The CO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned CO: Colleen Donahue-MacDonald Assigned CS: Stephen Showers

Organization or Agency: Network Contracting Office (NCO) 15

b. Contracting Officer’s Representative (COR) – The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

Assigned COR: Zakiyyah Stover Organization or Agency: Kansas City VA Medical Center, 4801 E. Linwood Blvd, Kansas City, MO 64128

3. CONTRACTOR REPRESENTATIVES

The following employee(s) of the contractor serve as the contractor’s program manager(s) for this contract.

Primary: Zakiyyah Stover Alternate: Leanne Anderson

Page 2 of 8 Version 0007 Date: 3/1/2018

4. PERFORMANCE STANDARDS

The contractor is responsible for performance of ALL terms and conditions of the contract. CORs will provide contract progress reports quarterly to the CO reflecting performance on this plan and all other aspects of the resultant contract. The performance standards outlined in this QASP shall be used to determine the level of contractor performance in the elements defined. Performance standards define desired services. The Government performs surveillance to determine the level of Contractor performance to these standards.

The Performance Requirements are listed below in Section 6. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the standard and assign a rating. At the end of the performance period, these ratings will be used, in part, to establish the past performance of the contractor on the contract.

5. METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

a. DIRECT OBSERVATION. 100% surveillance: Periodic Inspection of qualification documentation and records submitted in accordance with contractor reporting requirements.

b. PERIODIC INSPECTION.

c. RANDOM SAMPLING. Ten (10) randomly selected patient files will be reviewed per quarter. All reviews and reports will be conducted in compliance with VA Privacy and Information security standards.

d. Verification and/or documentation provided by Contractor. Review PWS and if this method of surveillance is selected, define how documentation will be verified and how assessment will be conducted. (For example, off-site contracts may require the contractor to provide information on services provided to patients).

Page 3 of 8 Version 0007 Date: 3/1/2018

6. QASP PERFORMANCE REPORT DATE: __________________

Measures PWS Reference

Performance Requirement

Standard Acceptable Quality Level

Surveillanc e

Method

Qualifications and Availability of Key Personnel

4.3.1.1 Medical Record Technicians and Cancer Tumor

Registrar and/or Cancer Registrars shall be certified in accordance with the recognized national standards as established by the National Cancer Registrars Association (NCRA) https://www.ncra-usa.org/CTR.

100% of care provided within NCRA standards

100% Periodic Inspection

Quality Assurance/Quality Improvement (QA/QI) Documentation

4.3.1.2. The Contractor shall conform to all ACOS

Commission on Cancer requirements relating to the National Cancer Database (NCDB), including timely accurate submissions; timely accurate resubmissions; correcting edits; and monitoring CoC flash newsletters to ensure compliance with all Cancer Registry and related deadlines, etc.

Cancer Registry data submitted by the Contractor to the NCDB shall meet the established quality criteria 100% of the time, as outlined in the NCDB Call for Data. Annually, cases submitted by the Contractor to the National Cancer Data Base (NCDB) that were diagnosed on January 1, 2019 or later meet the established quality criteria and resubmission deadlines as specified in the annual Call for Data.

100% of QA/QI documents complete in accordance with ACOS standards and reported as required to VA Radiation Oncology Service QA Committee.

90% Periodic Inspection Monthly

Abstracting oncology cases 4.3.1.3. The Contractor shall abstract oncology cases to ensure that all Commission on Cancer requirements/standards are met.

All (100%) 100% Periodic Inspection

Registry database requirements 4.3.1.4. The Contractor shall maintain follow-up at a minimum of 90% on all patients in the registry data base, this is required to use registry data for survival (outcome) analysis, which is industry standard.

All (100%) 100% completions

Periodic Sampling

Mandatory Training 4.3.1.5. Contractor shall complete all required training per VAMC policy.

All (100%) of required training is complete on time by Contractor’s physician(s).

90% completions

Page 4 of 8 Version 0007 Date: 3/1/2018

Privacy, Confidentiality and

HIPAA

4.3.1.6. Contractor is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA and complies with all standards Zero breaches of privacy or confidentiality.

All (100%) Contractor’s physician(s) comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and

HIPAA

90% compliance

Maintains licensing, registration, and certification

4.3.1.7. Updated Licensing, registration and certification

shall be provided as they are renewed. Licensing and registration information kept current.

All (100%) licensing, registration(s) and certification(s) for Contractor’s CRT/MRT (s) shall be provided as they are renewed. Licensing and registration information kept current.

100% compliance Periodic and Random

Page 5 of 8 Version 0007 Date: 3/1/2018

7. CPAR RATINGS ASSIGNED TO QASP ITEMS:

Metrics and methods are designed to determine rating for a given standard and acceptable quality level. The following ratings shall be used (Reference: CPARS User Manual https://www.cpars.gov/pdfs/CPARS-Guidance.pdf p. A2-1):

EXCEPTIONAL: Performance meets contractual requirements and exceeds many to the Government’s benefit. The contractual performance of the element or sub-element being assessed was accomplished with few minor problems for which corrective actions taken by the contractor were highly effective.

Note: To justify an Exceptional rating, you should identify multiple significant events in each category and state how it was a benefit to the GOVERNMENT. However, a singular event could be of such magnitude that it alone constitutes an Exceptional rating. Also, there should have been NO significant weaknesses identified.

VERY GOOD:

Performance meets contractual requirements and exceeds some to the Government’s benefit. The contractual performance of the element or sub-element being assessed was accomplished with some minor problems for which corrective actions taken by the contractor were effective.

Note: To justify a Very Good rating, you should identify a significant event in each category and state how it was a benefit to the GOVERNMENT. Also, there should have been NO significant weaknesses identified.

SATISFACTORY:

Performance meets contractual requirements. The contractual performance of the element or sub-element contains some minor problems for which corrective actions taken by the contractor appear or were satisfactory.

Note: To justify a Satisfactory rating, there should have been only minor problems, or major problems the contractor recovered from without impact to the contract. Also, there should have been NO significant weaknesses identified.

MARGINAL:

Performance does not meet some contractual requirements. The contractual performance of the element or sub-element being assessed reflects a serious problem for which the contractor has not yet identified corrective actions. The contractor’s proposed actions appear only marginally effective or were not fully implemented.

Note: To justify Marginal performance, you should identify a significant event in each category that the contractor had trouble overcoming and state how it impacted the GOVERNMENT. A Marginal rating should be supported by referencing the management tool that notified the contractor of the contractual deficiency (e.g. Management, Quality, Safety or Environmental Deficiency Report or letter).

UNSATISFACTO

RY: Performance does not meet most contractual requirements and recovery is not likely in a timely manner. The contractual performance of the element or sub-element being assessed contains serious problem(s) for which the contractor’s corrective actions appear or were ineffective.

Note: To justify an Unsatisfactory rating, you should identify multiple significant events in each category that the contractor had trouble overcoming and state how it impacted the GOVERNMENT. However, a singular problem could be of such serious magnitude that it alone constitutes an unsatisfactory rating. An Unsatisfactory rating should be supported by referencing the management tools used to notify the contractor of the contractual deficiencies (e.g. Management, Quality, Safety or Environmental Deficiency Reports, or letters).

https://www.cpars.gov/pdfs/CPARS-Guidance.pdf

Page 6 of 8 Version 0007 Date: 3/1/2018

8. DOCUMENTING PERFORMANCE

a. The Government shall document positive and/or negative performance. Any report may become a part of the supporting documentation for any contractual action and preparing annual past performance using CONTRACTOR

PERFORMANCE ASSESSMENT REPORT (CPAR).

b. If contractor performance does not meet the Acceptable Quality level, the CO shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the CO shall document the discussion and place it in the contract file. When the COR and the CO determines formal written communication is required, the COR shall prepare a Contract Report (CR), and present it to CO. The CO will in turn review and will present to the contractor's program manager for corrective action.

The contractor shall acknowledge receipt of the CR in writing. The CR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CR will also state how long after receipt the contractor has to present this corrective action plan to the CO. The Government shall review the contractor's corrective action plan to determine acceptability. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance and the acceptability of the Contractor’s corrective action plan.

Any CRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

See Sample on following page.

9. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

COR NAME/TITLE DATE

SIGNED:

CONTRACTOR NAME/TITLE DATE

Page 7 of 8 Version 0007 Date: 3/1/2018

CONTRACT REPORT

1. CONTRACT NUMBER 2. REPORT NUMBER FOR THIS DISCREPANCY

3. TO: (Contracting Officer) 4. FROM: (Name of COR)

5. DATES

a. CR PREPARED

b. RETURNED BY

CONTRACTOR:

c. ACTION COMPLETE

6. Issue Identified (Describe in detail. Include reference to PWS Directive; attach continuation sheet if necessary.)

7. SIGNATURE OF COR Date:

8. SIGNATURE OF CONTRACTING OFFICER Date:

9a. TO (Contracting Officer) 9a. FROM (Contractor)

10. CONTRACTOR RESPONSE AS TO CAUSE AND ACTIONS TO PREVENT RECURRENCE.

(Cite applicable quality control program procedures or new procedures. Attach continuation sheet(s) if necessary.)

11. SIGNATURE OF CONTRACTOR REPRESENTATIVE Date:

12. GOVERNMENT EVALUATION.

13. GOVERNMENT ACTIONS

14. CLOSE OUT

NAME TITLE SIGNATURE DATE

CONTRACTOR

NOTIFIED

COR

CONTRACTING

OFFICER

Page 8 of 8 Version 0007 Date: 3/1/2018